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Semaglutide för förebyggande av diabetes efter transplantation (SPOT-DM)

4 november 2026 uppdaterad av: Sunita Singh, MD, MSc, FRCPC, University Health Network, Toronto

The study aims to determine the short-term efficacy, mechanisms and safety of 24 weeks of semaglutide therapy in 37 KTR at risk of post-transplant diabetes mellitus (PTDM).

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

A kidney transplant is the best treatment for people living with kidney failure as it allows people to live longer with a better quality of life. However, one in four kidney transplant recipients will develop diabetes after transplant. This is largely due to the medications that must be used to prevent rejection of the transplant. Kidney transplant recipients who get diabetes after transplant are up to three times more likely to have heart disease and die prematurely. To date, there are no treatments to prevent the development of diabetes after kidney transplant. Semaglutide is a drug that is commonly used to treat diabetes and obesity. The investigators believe that semaglutide is a safe and effective drug which can prevent the development of diabetes in kidney transplant recipients. Therefore, the investigators are conducting a study where kidney transplant recipients who are at increased risk of developing diabetes after transplant will receive semaglutide for 24 weeks after their transplant. The study will determine whether semaglutide is effective in decreasing blood sugar levels and the rate of diabetes. The investigators will also study other important markers of health including body weight and cholesterol levels as well as liver, kidney and heart function. Diabetes after transplant is a common problem, and preventing it is extremely important to allowing kidney transplant recipients to live longer and better lives. The results of this study will allow the investigators to determine if semaglutide is a safe and effective option for the prevention of diabetes in kidney transplant recipients.

Studietyp

Interventionell

Inskrivning (Beräknad)

37

Fas

  • Fas 2
  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Kanada
    • British Columbia
      • Vancouver, British Columbia, Kanada, V6Z 1Y6
        • St. Paul's Hospital
        • Kontakt:
    • Ontario
      • Toronto, Ontario, Kanada, M5G 2N2
        • Toronto General Hospital
        • Kontakt:
        • Huvudutredare:
          • Sunita Singh, MD MSc FRCPC

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  1. Signed and dated written informed consent.

  2. Adult (≥18 years) recipients of a living or deceased donor kidney transplant

  3. Between 4- and 12-weeks post kidney transplant

  4. Stable kidney function defined as an eGFR > 30 ml/min/1.73m2 (CKD-EPI)

  5. At risk for PTDM at the time of transplant based on the following criteria:

    1. BMI ≥ 25 kg/m2, or
    2. Fasting plasma glucose 6.1-6.9 mmol/L (impaired fasting glucose), or
    3. 2hr OGTT plasma glucose 7.8-11.0 (impaired glucose tolerance), or
    4. HbA1C 5.5-6.4% (at risk for DM or prediabetes).

Exclusion Criteria:

  1. Established diagnosis of type 1 or type 2 DM as per Diabetes Canada (including the need for glucose-lowering therapy for hyperglycemia at the time of screening)
  2. Kidney-Pancreas transplant recipient
  3. Acute coronary syndrome, transient ischemic attack or stroke within 30 days prior to screening
  4. History of pancreatitis
  5. Personal or family history of medullary thyroid cancer or MEN2B
  6. Women who are pregnant, nursing or plan on becoming pregnant whilst in the trial
  7. Use of GLP1RA in the 30 days prior to screening
  8. Contraindication to MRI (applicable only to those undergoing the optional MRI assessments)
  9. With known or suspected hypersensitivity to semaglutide or related products
  10. Patient not able to understand and comply with study requirements, based on Investigator's judgment.
  11. Any other clinical condition that, based on Investigator's judgement, would jeopardize patient safety during trial participation or would affect the study outcom
  12. History of glucose-galactose malabsorption syndrome

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Semaglutide

Patients will be up-titrated as tolerated starting at 0.25 mg subcutaneous semaglutide once weekly for 4 weeks, followed by 0.5 mg, 1.0 mg, and 1.7 mg semaglutide for 4 weeks each, and then 2.4 mg subcutaneous semaglutide once weekly for 8 weeks. Semaglutide can be down-titrated by the investigator to lower doses or up-titrated at slower rates if not tolerated by the participant.
Läkemedel: Semaglutide 0.25 mg

Subcutaneous semaglutide 0.25mg for 4 weeks.

Läkemedel: Semaglutide 0.5 mg

Subcutaneous semaglutide 0.5mg for 4 weeks.

Läkemedel: Semaglutide 1.0 mg

Subcutaneous semaglutide 1.0 mg for 4 weeks.

Läkemedel: Semaglutide 1.7mg subcutaneous

Subcutaneous semaglutide 1.7 mg for 4 weeks

Läkemedel: Semaglutide 2.4 MG/0.75 ML Subcutaneous Solution [WEGOVY]

Subcutaneous semaglutide 2.4 mg for 8 weeks

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
2-hour OGTT
Tidsram: 24 weeks

The primary outcome of this study is the change in plasma glucose at 120 minutes following a 75g oral glucose challenge (2-hour OGTT) at 24 weeks. The 2-hour OGTT was selected as the primarily outcome in this study for the following reasons: 1) In selecting a surrogate outcome for PTDM in KTR, there are limitations to HbA1c and fasting glucose in this population; 2) The 2-hour OGTT is the recommended test for the diagnosis of PTDM in KTR and 3) The use of OGTT has been used in other PTDM prevention studies.
24 weeks

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Systoliskt blodtryck
Tidsram: 24 veckor
24 veckor
Förändring i kroppsvikt
Tidsram: 24 veckor
24 veckor
Förändring i midjemått
Tidsram: 24 veckor
24 veckor
Förändring i HbA1c
Tidsram: 24 veckor
24 veckor
Förändring i fastande blodglukos
Tidsram: 24 veckor
24 veckor
Förändring i seruminsulin
Tidsram: 24 veckor
24 veckor
Förändring i fasta lipidprofil
Tidsram: 24 veckor
24 veckor
Diastoliskt blodtryck
Tidsram: 24 veckor
24 veckor
Genomsnittlig arteriellt tryck
Tidsram: 24 veckor
24 veckor
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Tidsram: 24 weeks

: The side effects of GLP-1RA have been well described and will be assessed at each study visit. Adverse events include AKI, hypoglycemia, volume depletion, GI intolerance, amputations, pancreatitis, hepatobiliary complications and injection site or allergic reactions, infectious complications (any source), and malignancy. Episodes of biopsy-proven acute rejection (as defined by the Banff criteria), death-censored graft failure (defined as the need for initiation of chronic dialysis or re-transplantation) or death with graft function (defined as death with a functioning allograft) will also be collected. Kidney transplantation assures complete denervation of the transplanted kidney and the renal vasoconstrictive response in the setting of intravascular volume depletion is diminished in KTR. Therefore, frequent monitoring for adverse events has been integrated in our study design, occurring on 10 separate occasions, to capture these adverse events should they occur.
24 weeks
Estimated GFR
Tidsram: 24 weeks

Calculated by CKD-EPI 2021 equation
24 weeks
GFR
Tidsram: 24 weeks

Measured using 24-urine collection for creatinine, standardized per 1.73m2 body surface area. And estimated using CKD-EPI 2021 equation.
24 weeks
Albuminuria
Tidsram: 24 weeks

measuring urine albumin excretion from a 24-hour urine collection
24 weeks
Natriuresis
Tidsram: 24 weeks

Assessed with a 24-hour urine collection for sodium excretion
24 weeks
Percentage of body fat
Tidsram: 24 weeks

Bioimpedance analysis
24 weeks
Change in liver enzymes
Tidsram: 24 weeks

ALT and AST
24 weeks
Change in fibrosis level
Tidsram: 24 weeks

Transient elastography
24 weeks
Change in steatosis level
Tidsram: 24 weeks

Transient elastography
24 weeks
Percentage of extracellular fluid
Tidsram: 24 weeks

Bioimpedance analysis
24 weeks

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in kidney oxygenation (R2*)
Tidsram: 24 weeks

Assessed via multiparametric kidney MRI in an optional cohort.
24 weeks
Change in kidney fibrosis (ADC)
Tidsram: 24 weeks

Assessed via multiparametric kidney MRI in an optional cohort.
24 weeks
Change in kidney perfusion
Tidsram: 24 weeks

Assessed via multiparametric kidney MRI in an optional cohort.
24 weeks
Change in kidney volume
Tidsram: 24 weeks

Assessed via multiparametric kidney MRI in an optional cohort.
24 weeks
Change in kidney inflammation (T1)
Tidsram: 24 weeks

Assessed via multiparametric kidney MRI in an optional cohort.
24 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University Health Network, Toronto

Utredare

  • Huvudutredare: Sunita Singh, MD MSc FRCPC, University Health Network, Toronto General Hospital

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

5 december 2026

Primärt slutförande (Beräknad)

30 juni 2029

Avslutad studie (Beräknad)

30 december 2029

Studieregistreringsdatum

Först inskickad

17 mars 2025

Först inskickad som uppfyllde QC-kriterierna

2 april 2025

Första postat (Faktisk)

6 april 2025

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

5 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 25-5093

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

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produkt tillverkad i och exporterad från U.S.A.

Nej

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